Introduction to Medical Electronics Day 3: Medical Device Communications - Part 1 May 8, 2013 Charles J. Lord, PE President, Consultant, Trainer Blue Ridge Advanced Design and Automation

This Week’s Agenda 5/6 Medical Device Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

This Week’s Agenda 5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

The Challenge Worldwide today: 1 billion adults overweight 860 million individuals with chronic conditions 600 million individuals age 60 or older 75-85% of healthcare spending is on chronic condition management Many of the above are not close to the needed treatment or management centers

Opportunities in Medical Communications Clustering and tracking fitness or health for the consumer Remote tracking of fitness goals by a coach or mentor Remote tracking of medical conditions by caregivers Independent living

Connected Healthcare Pays! There is increasing evidence to support the value of remote monitoring for individuals with chronic conditions, including: •35-56% reduction in mortality; •47% reduction in risk of hospitalization; •6 days reduction in length of hospital admission and •65% reduction in office visits; •40-64% reduction in physician time for checks and •63% reduction in transport costs

Fitness, Wellness, and Weight Loss

Chronic Healthcare Management

Independent Living

Two Basic Levels of Interface Device to Aggregate (local collection device) Smart phone Tablet PC Specialized medical terminal Aggregate to Central Repository or direct to Caregiver

Local Collection Physical Layer USB (wired) ZigBee BT/LE WiFi Wired Ethernet Remaining OSI layers are supported by IEEE 11073 standard

ISO/IEEE 11073 Personal Health Device Standards Overview -00103 Technical Report - Overview OSI Device Specializations -10404 Pulse Oximeter -10407 Blood Pressure -10408 Thermo- meter -10415 Weighing Scale -10417 Glucose -10441 Cardio -10442 Strength -10471 Activity Data Phase II … Layers 5-7 -20601 Optimized Exchange Protocol Layers 1-4 Serial TCP/IP IrDA Communication Protocols Bluetooth USB ZigBee

Physical Layer - USB PHC (personal healthcare) profile is established by USB Implementers Forum (usb.org) Requires direct plug-in to aggregate Supported by virtually all aggregate Allows recharge of internal battery (for PC and dedicated, not with tablet and phone) Free from RF interference USB connector raises cleaning / environmental issues May use a charging / USB dock

Physical Layer - BlueTooth Power management an issue (LE compatibility with aggregate) Best interface for phones Works with many PCs No physical connection Limited range (1-2 m) Allows for an environmentally sealed device

Physical Layer – ZigBee® ZigBee Healthcare profile well established Requires a ZigBee device added to aggregate (dongle or custom aggregate) Low power impact No physical connection to device Allows for an environmentally sealed device Longer range than BT/LE (10+ m) Startup cost with ZigBee alliance

Other Physical Layers (future support) WiFi High power consumption Universal support for aggregate Long range (10+ m) Sealed device, no physical connection Growing support to make part of IoT (Internet of Things) Wired Ethernet No phone / tablet support Ideal for ‘hard wired’ devices that don’t move Can supply power through PoE Requires physical connector Serial, iRDA

Tying it all Together The Continua Alliance was formed as a non-profit by a team of manufacturers and healthcare providers to provide a total structure from device to aggregate to central repository to health providers (from wellness coaches to critical care doctors) Built on ISO/IEEE 11073 Maintain federal standards (HIPAA, Part 11, etc)

Continua Alliance “Our Mission is to establish an ecosystem of interoperable personal connected health systems that empower individuals and organizations to better manage their health and wellness” www.continuaalliance.org

Back to 11073 The device (as we have been calling it) is referred to as the “Agent” The collector of the information (“aggregate”) is the “Manager” Majority of responsibility for the protocol falls on the Manager (similar to USB, ZigBee, etc) Allows for less computation, lower power for the portable Agent device An Agent talks to one Manager, or may be unassociated with any Manager (when not communicating)

ISO/IEEE 11073 Personal Health Device Standards Overview -00103 Technical Report - Overview OSI Device Specializations -10404 Pulse Oximeter -10407 Blood Pressure -10408 Thermo- meter -10415 Weighing Scale -10417 Glucose -10441 Cardio -10442 Strength -10471 Activity Data Phase II … Layers 5-7 -20601 Optimized Exchange Protocol Layers 1-4 Serial TCP/IP IrDA Communication Protocols Bluetooth USB ZigBee

Tomorrow – 11073 in more detail Overall structure End-to-end examples of a device (Agent) Association Connection Communications How each protocol ties together Physical (USB PHC, ZigBee HC, etc) ISO/IEEE 11073 Continua

This Week’s Agenda 5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

Please stick around as I answer your questions! Please give me a moment to scroll back through the chat window to find your questions I will stay on chat as long as it takes to answer! I am available to answer simple questions or to consult (or offer in-house training for your company) c.j.lord@ieee.org http://www.blueridgetechnc.com